24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus
Intervention: rosiglitazone-metformin fixed dose combination (Drug); metformin + glimepiride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
A better glycemic control is associated with less complications (cardiac diseases,
blindness, etcetera) for type 2 diabetic patients. The objective is to study if
rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and
hypoglycemia episodes than with a sulphonylurea (glimepiride).
Clinical Details
Official title: Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on TreatmentEpisodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Secondary outcome: Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on TreatmentEpisodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment HbA1c (Glycosylated Hemoglobin) 8-Iso Prostaglandin F2α (8-Iso PGF2α) Excretion Rate Glycaemia According to CGMS (Nocturnal), mg/dL Glycaemia According to CGMS (Diurnal), mg/dL Glycaemia According to CGMS (Dawn), mg/dL Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL Glycaemia According to CGMS (MAGE), mg/dL
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females aged 40 to 80 years
- Diagnosis of type 2 diabetes mellitus for at least 6 months
- Body mass index (BMI) ≥25kg/m2
- 7%≥HbA1c ≤ 9% at visit 2
- Treatment with metformin between 1. 7g/day and 3g/day for at least 12 weeks prior to
visit 1
- Female subjects must be non-pregnant, post-menopausal, surgically sterile or using
effective contraceptive measures
- Written informed consent
Exclusion Criteria:
- Use of any oral antidiabetic drug other than metformin within 12 weeks prior to
screening
- Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds
with similar chemical structure
- Subjects who have required the use of insulin for glycaemic control at any time in
the past or subject with a history of metabolic acidosis including diabetic
ketoacidosis
- Subjects with clinically significant ongoing oedema or with a history of oedema in
the 12 months prior to visit 1
- Subjects with a history of severe hypoglycaemia
- Anemia defined by haemoglobin concentration <11. 0g/dL for males or <10. 0g/dL for
females
- Renal disease or renal dysfunction, e. g. as suggested by serum creatinine levels
≥135µmol/L in males and ≥110µmol/L in females
- Presence of clinically significant hepatic disease (i. e. ALT, AST, total bilirubin or
alkaline phosphatase >2. 5 times the upper limit of the normal reference range)
- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent
myocardial infarction
- Subjects with chronic diseases requiring periodic or intermittent treatment with oral
or intravenous corticosteroids
- Female who are lactating, pregnant, or planning to become pregnant
- Any clinically significant abnormality identified at screening which in the judgement
of the investigator makes the subject unsuitable for inclusion in the study (e. g.
physical examination, laboratory test, ECG, ...)
- Use of any investigational agent within 30 days or 5 half-lives (whichever is longer)
prior to enrolment in this study
- Active alcohol, drug or medication abuse within the last 6 months or any condition
that would indicate the likelihood of poor subject compliance
- Subjects not willing to comply with the procedures described in this protocol.
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: April 10, 2009
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